Status:
COMPLETED
Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
Brief Summary
This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes cu...
Eligibility Criteria
Inclusion
- Type 2 diabetes treated with biphasic human insulin with or without metformin
- Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50
Exclusion
- Subjects with diagnosed type 1 diabetes mellitus
- Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
- Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
- Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
- Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00755833
Start Date
September 1 2008
End Date
April 1 2010
Last Update
October 31 2016
Active Locations (1)
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1
Novo Nordisk Investigational Site
Ljubljana, Slovenia, SI-1000